A Study of LY3537031 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3537031; Drug: Placebo

• Registration Number: NCT04648865
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2020-12-09
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2021-06-15
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Are male or female not of childbearing potential
• Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg)
• Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
• Have veins suitable for blood sampling

Exclusion Criteria

• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Have a diagnosis or history of cancer or malignant disease within 5 years
• Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening
• Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
• Have undergone any form of bariatric surgery
• Have previously completed or withdrawn from this study
• Are currently participating in or completed a clinical trial within the last 3 months
• Regularly use known drugs of abuse or with positive drug results
• Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537031	LY3537031	LY3537031 administered subcutaneously (SC).
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through final follow-up at approximately Day 43	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031	Baseline through final follow-up at approximately Day 43	PK: AUC of LY3537031
PK: Maximum Concentration (Cmax) of LY3537031	Baseline through final follow-up at approximately Day 43	PK: Cmax of LY3537031

Trial Locations

Locations (1)

Clinical Research Hospital Tokyo; 🇯🇵 Shinjuku-ku, Tokyo, Japan